Regulatorische Updates

The FDA reports that certain bottles may contain mixed strengths of the product, prompting a recall.

The Pharmaceuticals and Medical Devices Agency (PMDA) announced the launch of its new “Designation / Early Access” website, providing information on early access pathways.

The Pharmaceuticals and Medical Devices Agency (PMDA) has launched a new website offering an overview of Japan’s orphan drug designation process.

The Pharmaceuticals and Medical Devices Agency (PMDA) has posted the schedule for the upcoming JP19‑I publication.

The Pharmaceuticals and Medical Devices Agency (PMDA) has posted the report from the PMDA-ATC 10th Anniversary Ceremony.

The Pharmaceuticals and Medical Devices Agency (PMDA) announced a new project team to develop guiding principles for AI utilization, listed under its “Projects Across Multi‑Offices” initiative.

The Pharmaceuticals and Medical Devices Agency (PMDA) posted its PDG March 2026 news on June 12, 2026.

The Pharmaceuticals and Medical Devices Agency (PMDA) has posted the report for its 2026 Asia Office GMP Workshop Training.

Japan’s Pharmaceuticals and Medical Devices Agency has released an updated list of drugs approved from April 2004 through February 2026. The list is available on the PMDA website.

The Pharmaceuticals and Medical Devices Agency (PMDA) announced the conclusion of a Memorandum of Understanding with the Medical University of Vienna, as detailed in a June 30, 2026 news release.

The Pharmaceuticals and Medical Devices Agency (PMDA) has posted Safety Information No.429, providing recent safety updates for drugs and devices in Japan.

The Pharmaceuticals and Medical Devices Agency (PMDA) has posted the summary of the 8th Asian Network Meeting on its website.